18 and older, any sex, with Cutaneous T-cell Lymphoma or Cutaneous T-cell Lymphoma Stage I. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Moderate to Severe Contact Dermatitis by SCORD ScoringPrimary· 4 months
Incidence of moderate to severe contact dermatitis in patients treated concurrently with Triamcinolone 0.1% ointment versus those that are not. Dermatitis will be defined as a finding of cutaneous inflammatory reaction occurring as a result of treatment. This will be assessed by the SCORD (SCORing Dermatitis) tool and may be confirmed by biopsy of the specimen. Moderate to Severe Contact dermatitis is defined as \>25 by SCORD.
Group
Value
95% CI
Valchlor 0.016% Topical Gel
16
Valchlor Plus Triamcinolone
11
Nature of Contact Dermatitis (Allergic Versus Irritant)Secondary· 4 months
The presence of allergic versus irritant dermatitis was characterized through skin biopsies sent for pathological review and patch testing. Subjects presenting to the clinic with dermatitis underwent patch testing to determine the presence of allergic vs. Irritant contact dermatitis, and at each case a biopsy sample was taken of the affected area to confirm the diagnosis. Patch testing was assessed by the investigator according to the International Contact Dermatitis Research Group scale, using the following for possible outcomes : ?+ indicates a doubtful reaction, 1+ indicates a weak reaction
Group
Value
95% CI
All Participants
2
All Participants
10
Severity of DermatitisSecondary· 4 months
Scoring Atopic Dermatitis (SCORAD) differences between lesions treated with Valchlor and Triamcinolone versus lesions treated with Valchlor only. SCORAD measures the extent and severity of dermatitis. The percentage of total body surface area (0-100) covered by a lesion is measured by an investigator, and this number corresponds to score "A." The intensity criteria are met by scoring erythema, edema/papulation, oozing/crusting, excoriation, xerosis, and thickness on a scale of 0-3 (0=none, 1=mild, 2=Moderate, 3=Severe). These values are summed to give a total score, "B." Subjective symptoms of
Group
Value
95% CI
Valchlor 0.016% Topical Gel
24.8
± 21.8
Valchlor Plus Triamcinolone
12.7
± 13.5
Efficacy of Valchlor vs Valchlor Plus TriamcinoloneSecondary· 4 months
Efficacy of Valchlor therapy with Triamcinolone compared to Valchlor using a composite assessment of index lesion severity (CAILS). CAILS is an objective, quantitative, method to assess the extent of skin lesions. Skin lesions and erythema will be evaluated using CAILS. A Composite Assessment will be generated for each time point by a summation of the grades for each index lesion's erythema, scaling, plaque elevation, hypopigmentation or hyperpigmentation, and area of involvement. The index lesion grade at baseline will be divided into the grade at each subsequent study visit to determine the
Average CAILS score at Baseline
Group
Value
95% CI
Valchlor 0.016% Topical Gel
8.6
± 4.2
Valchlor Plus Triamcinolone
7.0
± 5.1
Average CAILS score at Month 4
Group
Value
95% CI
Valchlor 0.016% Topical Gel
11.4
± 4.9
Valchlor Plus Triamcinolone
12.0
± 4.85
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a two-arm, open-label study that aims to compare the incidence and severity of the most common adverse reactions, particularly contact dermatitis, when Valchlor is used alone or in conjunction with triamcinolone ointment 0.1% in early stage MF subjects (Stage IA and IB) for a period of 4 months.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rochester Skin Lymphoma Medical Group, PLLC
Last refreshed: 24 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03380026.